THE LONG-TERM SAFETY OF ALPROSTADIL (PROSTAGLANDIN-E-1) IN PATIENTS WITH ERECTILE DYSFUNCTION

Objective To evaluate the long-term safety and efficacy of intracavern osal alprostadil (prostaglandin E-1, PGE(1)) in patients with erectile dysfunction [ED) and assess the feasibility of self-injection treatme nt, Patients and methods The study included 848 men (aged 18-75 years) with ED of greater than or equal to 4 months' duration. The initial h ome-use dose of alprostadil, defined as a dose producing an erection s atisfactory for intercourse and lasting for greater than or equal to 2 0 min, was determined for each patient in the investigator's clinic an d in the patient's home. This dose-finding phase was followed by a 6-m onth, self-injection, home-maintenance phase. The efficacy and adverse effects were documented. Results An initial home-use dose was determi ned for 93% of the patients and in most (86%) it was less than or equa l to 20 mu g. During the 6-month study period, 88% of injections asses sed by the patients resulted in satisfactory sexual activity (intercou rse or masturbation) and 90% of injections assessed, by partners resul ted in satisfactory intercourse. Penile pain occurred in 44% of patien ts, but this incidence decreased with time. In 52% of patients with pa in it was mild and only 3% of patients discontinued the study because of pain. Prolonged erection and priapism occurred in 8% and 0.9% of pa tients, respectively, Penile fibrosis occurred in 4% of patients. Drug -related systemic medical events occurred in 5%, of patients and none of these were serious. Haemodynamic events occurred in <I% of patients and were not considered to be clinically relevant. Conclusion Intraca vernosal alprostadil is an effective and safe therapy for EU, provided that the individual dose is established by titration, patients are tr ained in the self-injection technique and supervised periodically.